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Placebo tablet and budesonide
Budesonide is a corticosteroid that reduces inflammation by suppressing immune response and inflammatory mediator production in the airways and gastrointestinal tract.
Budesonide is a corticosteroid that reduces inflammation by suppressing immune response and inflammatory mediator production in the airways and gastrointestinal tract. Used for Asthma (maintenance therapy), Chronic obstructive pulmonary disease (COPD), Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
At a glance
| Generic name | Placebo tablet and budesonide |
|---|---|
| Also known as | Placebo tablet and Budesonide. |
| Sponsor | Medical University of Lodz |
| Drug class | Corticosteroid (inhaled or oral formulation) |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Budesonide binds to glucocorticoid receptors in the cytoplasm, translocates to the nucleus, and modulates gene transcription to decrease production of pro-inflammatory cytokines, chemokines, and adhesion molecules. This reduces airway inflammation, mucus production, and immune cell infiltration. The placebo control arm allows for comparison of budesonide's efficacy against baseline disease progression.
Approved indications
- Asthma (maintenance therapy)
- Chronic obstructive pulmonary disease (COPD)
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Common side effects
- Oral candidiasis
- Tremor
- Headache
- Dysphonia
- Throat irritation
- Systemic corticosteroid effects (with higher doses)
Key clinical trials
- Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis (PHASE4)
- A Trial on the Treatment of Bronchial Asthma With Budesonide Formoterol Combined With Immune Modulators (Staphylococcus and Neisseria Tablets) (PHASE3)
- Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254) (PHASE4)
- Repurposed Approved and Under Development Therapies for Patients With Early-Onset COVID-19 and Mild Symptoms (PHASE3)
- Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis (PHASE3)
- (CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis. (PHASE3)
- (CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis (PHASE3)
- (CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo tablet and budesonide CI brief — competitive landscape report
- Placebo tablet and budesonide updates RSS · CI watch RSS
- Medical University of Lodz portfolio CI